NCT00508547

Brief Summary

The purpose of this study is to further evaluate the safety of infliximab, ustekinumab, and guselkumab in patients with plaque and other forms of psoriasis. The study also includes patients receiving other therapies, such as non-biologic and other biologic agents. The registry also evaluates patient and disease characteristics, including patient-reported assessment of psoriatic arthritis (PsA); and clinical and quality of life outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
15,842

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
20 countries

310 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jun 2007Dec 2030

Study Start

First participant enrolled

June 21, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
22.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

22.5 years

First QC Date

July 27, 2007

Last Update Submit

April 9, 2026

Conditions

Keywords

psoriasispsoriatic arthritisskin diseaseinfliximabustekinumabguselkumabetanerceptadalimumabsecukinumabixekizumabbrodalumabsystemic therapyobservationalregistry

Outcome Measures

Primary Outcomes (1)

  • Adverse Events and Serious Adverse Events

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; suspected transmission of any infectious agent via medicinal product; any important medical events. All adverse events, including those of special interest, such as malignancies;TB;opportunistic infections;depression;hypersensitivity reactions; autoimmune disease; neurologic or demyelinating events; congestive heart failure; gastrointestinal events; demyelinating disease, hepatotoxicity; hematologic events; unexpected reaction to a vaccine;cerebrovascular accident; transient ischemic attack; confirmed myocardial infarction; acquired immunodeficiency syndrome will be documented.

    Up to 8 years of follow up for each patient

Secondary Outcomes (6)

  • Evaluation of disease features: Physicians global assessment of disease activity (PGA) Score

    At baseline and every 6 months through up to 8 years

  • Evaluation of Disease Features: Body surface area

    At baseline and every 6 months through up to 8 years

  • Evaluation of Disease Features: Psoriasis Area and Severity Index (PASI) Score

    At baseline and every 6 months through up to 8 years

  • Dermatology Life Quality Index (DLQI) Score

    At baseline and every 6 months through up to 8 years

  • EuroQOL quality of life assessment

    At baseline and every 6 months through up to 8 years

  • +1 more secondary outcomes

Study Arms (6)

Guselkumab

Participants will receive guselkumab as prescribed by a physician according to standard of care for psoriasis.

Infliximab

Participants will receive infliximab as prescribed by a physician according to standard of care for psoriasis.

Ustekinumab

Participants will receive ustekinumab as prescribed by a physician according to standard of care for psoriasis.

Biological Therapies

Participants will receive biological therapies other than infliximab, ustekinumab, guselkumab, and IL-17 inhibitors as prescribed by a physician for psoriasis. Participants will not receive any intervention as a part of this study.

Conventional Systemic Agents

Participants will receive conventional systemic agents as prescribed by a physician for psoriasis. Participants will not receive any intervention as a part of this study.

IL-17 Inhibitor

Participants will receive an IL-17 inhibitor as prescribed by a physician according to standard of care for psoriasis.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient with psoriasis who meets the inclusion criteria will be eligible to participate in this registry.

You may qualify if:

  • Have a diagnosis of psoriasis
  • Incident or prevalent users of Tremfya or an IL-17 inhibitor (eg, secukinumab, ixekizumab, brodalumab, bimekizumab) at the time of their enrollment. Incident users are defined as those participants starting treatment within 30 days before or after the enrollment visit and prevalent users are defined as those who are on treatment greater than 30 days prior to the enrollment visit
  • Ability to understand and sign an informed consent form
  • Are willing to participate in regular follow-up visits

You may not qualify if:

  • Refuse to consent or are unwilling to respond to requests for long term information within the required time frame
  • Are participating or have already planned to participate in a clinical trial with non-marketed investigational agents or are participating in a Janssen-sponsored clinical trial with marketed agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (320)

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Birmingham, Alabama, United States

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Florence, Alabama, United States

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Rogers, Arkansas, United States

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Bakersfield, California, United States

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Clovis, California, United States

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Fountain Valley, California, United States

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Fresno, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Mountain View, California, United States

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Oxnard, California, United States

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Redding, California, United States

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Rolling Hills Estates, California, United States

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San Diego, California, United States

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San Ramon, California, United States

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Santa Monica, California, United States

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Sherman Oaks, California, United States

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Upland, California, United States

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Vallejo, California, United States

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Colorado Springs, Colorado, United States

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Englewood, Colorado, United States

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Bridgeport, Connecticut, United States

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Farmington, Connecticut, United States

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Newark, Delaware, United States

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Wilmington, Delaware, United States

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Washington D.C., District of Columbia, United States

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Aventura, Florida, United States

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Bay Pines, Florida, United States

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Boca Raton, Florida, United States

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Boynton Beach, Florida, United States

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Coral Gables, Florida, United States

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Delray Beach, Florida, United States

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Dunedin, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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North Miami Beach, Florida, United States

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Panama City, Florida, United States

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Pembroke Pines, Florida, United States

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Seminole, Florida, United States

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Tampa, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Birmingham, Georgia, United States

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Carrollton, Georgia, United States

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Conyers, Georgia, United States

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Lilburn, Georgia, United States

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Macon, Georgia, United States

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Marietta, Georgia, United States

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Rome, Georgia, United States

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Twin Falls, Idaho, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Lincolnshire, Illinois, United States

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Maywood, Illinois, United States

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Rolling Meadows, Illinois, United States

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Schaumburg, Illinois, United States

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Skokie, Illinois, United States

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Springfield, Illinois, United States

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West Dundee, Illinois, United States

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Winfield, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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New Albany, Indiana, United States

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Plainfield, Indiana, United States

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West Lafayette, Indiana, United States

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Topeka, Kansas, United States

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Corbin, Kentucky, United States

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Lexington, Kentucky, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Quincy, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Clarkston, Michigan, United States

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Clinton Township, Michigan, United States

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Farmington, Michigan, United States

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Flint, Michigan, United States

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Fort Gratiot, Michigan, United States

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Grand Blanc, Michigan, United States

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Grand Rapids, Michigan, United States

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Monroe, Michigan, United States

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Norton Shores, Michigan, United States

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Troy, Michigan, United States

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Warren, Michigan, United States

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Eagan, Minnesota, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Helena, Montana, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Nashua, New Hampshire, United States

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Belleville, New Jersey, United States

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East Windsor, New Jersey, United States

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Hoboken, New Jersey, United States

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Marlton, New Jersey, United States

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Rutherford, New Jersey, United States

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Somerset, New Jersey, United States

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Verona, New Jersey, United States

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Wyckoff, New Jersey, United States

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Auburn, New York, United States

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Commack, New York, United States

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East Syracuse, New York, United States

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Elmhurst, New York, United States

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Garden City, New York, United States

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Huntington, New York, United States

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Lawrence, New York, United States

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New York, New York, United States

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Oceanside, New York, United States

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Rochester, New York, United States

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Smithtown, New York, United States

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Staten Island, New York, United States

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Stony Brook, New York, United States

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Suffern, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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White Plains, New York, United States

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Williamsville, New York, United States

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Chapel Hill, North Carolina, United States

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Raleigh, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Wilmington, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Delaware, Ohio, United States

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Gahanna, Ohio, United States

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Warren, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Coos Bay, Oregon, United States

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Portland, Oregon, United States

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Exton, Pennsylvania, United States

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Fort Washington, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Plymouth Meeting, Pennsylvania, United States

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Charleston, South Carolina, United States

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Fort Mill, South Carolina, United States

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Piedmont, South Carolina, United States

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Spartanburg, South Carolina, United States

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Bartlett, Tennessee, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Arlington, Texas, United States

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Cedar Hill, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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Salt Lake City, Utah, United States

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Arlington, Virginia, United States

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Norfolk, Virginia, United States

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Kennewick, Washington, United States

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Mount Vernon, Washington, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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University Place, Washington, United States

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Walla Walla, Washington, United States

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Green Bay, Wisconsin, United States

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Pleasant Prairie, Wisconsin, United States

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Sheboygan, Wisconsin, United States

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Buenos Aires, Argentina

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CABA, Argentina

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Cipolletti, Argentina

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Lomas de Zamora, Argentina

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San Miguel, Argentina

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Fremantle, Australia

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Melbourne, Australia

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Miranda, Australia

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Sydney, Australia

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Woolloongabba, Australia

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Althofen, Austria

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Feldkirch, Austria

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Graz, Austria

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Klagenfurt, Austria

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Laakirchen, Austria

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Sankt Pölten, Austria

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Vienna, Austria

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Villach, Austria

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Bruges, Belgium

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Brussels, Belgium

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Edegem, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Mons, Belgium

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Nanaimo, British Columbia, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Fredericton, New Brunswick, Canada

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Moncton, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Kentville, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Coburg, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Mississauga, Ontario, Canada

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Newmarket, Ontario, Canada

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North Bay, Ontario, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Saint Catherines, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Drummondville, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Santiago, Chile

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Santiago - Las Condes, Chile

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Santiago - Macul, Chile

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Bogotá, Colombia

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MedellĂ­n, Colombia

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Brno, Czechia

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České Budějovice, Czechia

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Jihlava, Czechia

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Náchod, Czechia

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NovĂ˝ JiÄŤĂ­n, Czechia

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Olomouc, Czechia

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Pardubice, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Ĺ umperk, Czechia

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ĂšstĂ­ nad Labem, Czechia

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Athens, Greece

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Heraklion, Greece

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Ioannina, Greece

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Larissa, Greece

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Pátrai, Greece

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Piraeus-Athens, Greece

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PsychikĂł, Greece

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Thessaloniki, Greece

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Afula, Israel

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Beersheba, Israel

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Haifa, Israel

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Netivot, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Hirakata, Japan

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Hokkaido, Japan

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Itabashi Ku, Japan

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Kobe, Japan

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Kurume, Japan

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Matsumoto, Japan

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ĹŚita, Japan

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Takamatsu, Japan

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Tokyo, Japan

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Tsu, Japan

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Yokosuka, Japan

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Estado de México, Mexico

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Mexico City, Mexico

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Monterrey, Mexico

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Zapopan, Mexico

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Alkmaar, Netherlands

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Amsterdam-Zuidoost, Netherlands

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Breda, Netherlands

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Deventer, Netherlands

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Helmond, Netherlands

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Nijmegen, Netherlands

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Braga, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Vila Nova de Gaia, Portugal

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Košice, Slovakia

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Martin, Slovakia

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Nitra, Slovakia

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Poprad, Slovakia

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Prešov, Slovakia

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Trnava, Slovakia

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Celje, Slovenia

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Izola, Slovenia

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Kranj, Slovenia

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Ljubljana, Slovenia

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Maribor, Slovenia

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Busan, South Korea

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Gyeonggi-do, South Korea

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Seongnam-si, South Korea

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Seoul, South Korea

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Sungnam, South Korea

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Alcalá de Henares, Spain

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Bilbao, Spain

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Granada, Spain

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Madrid, Spain

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Majadahonda, Spain

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Murcia, Spain

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Salamanca, Spain

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Santiago de Compostela, Spain

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Eskilstuna, Sweden

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Gothenburg, Sweden

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Kungsbacka, Sweden

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Stockholm, Sweden

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Dnipro, Ukraine

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Donetsk, Ukraine

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Kharkiv, Ukraine

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Khmelnitskiy, Ukraine

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Kiev, Ukraine

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Luhansk, Ukraine

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Simferopol, Ukraine

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Uzhhorod, Ukraine

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Related Publications (5)

  • Ritchlin CT, Stahle M, Poulin Y, Bagel J, Chakravarty SD, Kafka S, Srivastava B, Langholff W, Gottlieb AB. Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics. BMC Rheumatol. 2019 Nov 28;3:52. doi: 10.1186/s41927-019-0094-3. eCollection 2019.

  • Kavanaugh A, Papp K, Gottlieb AB, de Jong EMGJ, Chakravarty SD, Kafka S, Langholff W, Farahi K, Srivastava B, Scher JU. Demography, baseline disease characteristics, and treatment history of psoriasis patients with self-reported psoriatic arthritis enrolled in the PSOLAR registry. BMC Rheumatol. 2018 Sep 29;2:29. doi: 10.1186/s41927-018-0034-7. eCollection 2018.

  • Singh S, Kalb RE, de Jong EMGJ, Shear NH, Lebwohl M, Langholff W, Hopkins L, Srivastava B, Armstrong AW. Effect of Age of Onset of Psoriasis on Clinical Outcomes with Systemic Treatment in the Psoriasis Longitudinal Assessment and Registry (PSOLAR). Am J Clin Dermatol. 2018 Dec;19(6):879-886. doi: 10.1007/s40257-018-0388-z.

  • Strober BE, Bissonnette R, Fiorentino D, Kimball AB, Naldi L, Shear NH, Goyal K, Fakharzadeh S, Calabro S, Langholff W, You Y, Galindo C, Lee S, Lebwohl MG. Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR]). J Am Acad Dermatol. 2016 May;74(5):851-61.e4. doi: 10.1016/j.jaad.2015.12.017. Epub 2016 Feb 4.

  • Kalb RE, Fiorentino DF, Lebwohl MG, Toole J, Poulin Y, Cohen AD, Goyal K, Fakharzadeh S, Calabro S, Chevrier M, Langholff W, You Y, Leonardi CL. Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis: Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). JAMA Dermatol. 2015 Sep;151(9):961-9. doi: 10.1001/jamadermatol.2015.0718.

MeSH Terms

Conditions

PsoriasisArthritis, PsoriaticSkin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Officials

  • Janssen Scientific Affairs, LLC Clinical Trial

    Janssen Scientific Affairs, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 30, 2007

Study Start

June 21, 2007

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations